MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON TORIC UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCW0T5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Zonular Dehiscence (2698)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history records were reviewed, and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non healthcare professional reported following an intraocular lens (iol) implant procedure, the patient another eye matter complicated iol staying in eye.The lens was explanted and replaced with unspecified lens in a secondary procedure.Additional information has been received and stated that the patient had a spontaneous 360 degree capsule zonular dehiscence after iol was implanted and it was removed during initial procedure, replaced with another lens.There was no problem with the iol.Patient had complication that required the iol to be cut out and 3 piece inserted.No patient impact was reported and issue was resolved.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.It is stated in the file attachment and follow up details that there was no problem with the iol.Pt had complication that required the iol to be cut out and 3 piece inserted.The root cause for the reported complaint appears to be a coincidental event that was unrelated to the product as user facility reported that there was no problem with the iol.Pt had complication that required the iol to be cut out and 3 piece inserted.Based on this information, the product did not cause or contribute to the event.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21933854
• Report Number: 9612169-2025-00942
• Device Sequence Number: 8907358
• Product Code: MJP
• UDI-Device Identifier: 00380652434072
• UDI-Public: (01)00380652434072(17)261031(11)221102(10)25528211
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CCW0T5
• Device Catalogue Number: CCW0T5.260
• Device Lot Number: 25528211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 07/08/2025
• Date Device Manufactured: 11/02/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC.; MONARCH III IOL, CARTRIDGE D.; MONARCH III IOL, INJECTOR.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female